Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053430
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2003-01-29
Brief Title:
Using the Drug Thalidomide to Stimulate T Cells in HIV-Infected People
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pharmacologic T Cell Costimulation In HIV Disease
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite treatment with anti-HIV drugs people infected with HIV continue to have problems with their immune systems This study will evaluate whether the drug thalidomide which stimulates the immune systems T cells can improve immune system function in people with HIV
Detailed Description:
In patients with chronic HIV infection HIV replication and abnormalities in immune function persist following treatment with highly active antiretroviral therapy HAART Specifically costimulatory T cell interactions are impaired The immune modulatory drug thalidomide was recently found to costimulate T cells Pharmacologic T cell costimulation may compensate for the T cell deficiencies in people with HIV disease and improve immune function This study will test whether thalidomide treatment enhances HIV and cytomegalovirus CMV-specific immunity in patients with HIV and CMV and will evaluate the effect of thalidomide on HIV replication
In this study 40 HIV and CMV infected patients on HAART and 40 HIV uninfected CMV seropositive controls will be randomly assigned to low dose thalidomide or placebo treatment for 28 days T cell responses and HIV replication and genetic diversification will be assessed
In this study 40 HIV and CMV infected patients on HAART and 40 HIV uninfected CMV seropositive controls will be randomly assigned to low dose thalidomide or placebo treatment for 28 days T cell responses and HIV replication and genetic diversification will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 7R01AI047742-02 | NIH | None | httpsreporternihgovquickSearch7R01AI047742-02 |